1. Field of the Invention
The present invention relates to a method of reducing the buildup of the amount of calcified arterial plaque and reducing cellular malfunction with the administration of an adequate quantity of the biochemically and physiologically important mineral salt magnesium (Mg) and more particularly a more biologically active form of magnesium known as compound complex magnesium. In addition, the present invention relates to a method of balancing ionic calcium with the administration of an adequate quantity of the biochemically and physiologically important mineral salt calcium (Ca) and more particularly a more biologically active form of calcium known as compound complex calcium that does not contribute to calcified arterial plaque buildup and cellular malfunction.
2. Background Art
Magnesium salts are essential in human nutrition. As part of adenosine triphosphate (ATP), magnesium is required for all biosynthetic processes, glycolysis, formation of cyclic adenosine monophosphate (cyclic AMP), is involved in energy metabolism and energy dependent membrane transport, and is required for ribonucleic acid (RNA) synthesis and transmission of the genetic code. Magnesium salts (a cation) are required for the activity of more than 300 enzymes (either by interaction between substrate and an active site or by induction of conformational change), and especially those enzymes concerned with oxidative phosphorylation. Magnesium salts are an important component of both intracellular and extracellular fluids. Intracellular magnesium is believed to control cellular metabolism by modulating the activity of rate limiting enzymes. Extracellular magnesium is critical to the maintenance of electrical potentials of nerve and muscle membranes and for transmission of impulses across neuromuscular junctions. Magnesium salts are important in maintaining the homeostasis of cardiac and smooth muscle tissues. In each of these physiological processes there is an interaction with the mineral salt calcium, which may act synergistically or antagonistically.
It is believed that there are 20 to 28 grams of magnesium in the adult human body. Approximately 59% is in the body""s skeleton and bone structures, approximately 40% is in the body""s musculature and soft body tissues, with approximately 1% (about 2 to 2.8 grams) in the body""s extracellular fluid. Serum concentration ranges from 1.1 to 2.1 mEq/l in healthy individuals and is believed to be regulated primarily by the kidneys. Kidney filterable magnesium (serum magnesium not bound to protein) is either reabsorbed in the kidneys"" proximal convoluted tubule or in Henle""s loop, which is where major adjustments in response to serum concentrations are believed to take place. There is a passive equilibrium between a portion of skeletal magnesium and that in the blood which is believed to act as a modulator against fluctuations in extracellular magnesium concentrations.
Magnesium balances calcium and its functions within the human body. It is believed that the adult human body contains approximately 1200 grams of calcium, with approximately 99% of it in the skeleton, and approximately 1% (about 12 grams) in extracellular fluids, intracellular structures, and cell membranes. This approximately 1% plays an essential role, in conjunction with magnesium, in the functions of nerve conduction, muscle contraction, blood clotting, and membrane permeability. It is believed that serum calcium concentration is maintained by several hormones, including estrogen and testosterone. It is known that dietary protein enhances calcium absorption, and dietary phosphorus causes calcium retention.
Magnesium deficiency is known to cause nausea, muscle weakness, neuromuscular and cardiac irritability, tetany, convulsions, tremors, mental depression, psychotic behavior, inhibit proper muscle function and contractions, as well as interfere with the proper utilization of calcium and potassium.
Magnesium is inorganic and is not produced by the human body. Humans must rely upon dietary sources to provide the body with its magnesium requirements. Magnesium is a natural component of the earth""s crust and finds its way into the diet of humans from the food products grown in soil. Foods containing the highest concentration of magnesium are unprocessed whole grains, legumes, seeds, and chlorophyll containing green plant foods (the central atom of chlorophyll molecules is magnesium). More than 80% of the magnesium content of unmilled grains are lost by removal of the germ portion and by the removal of the outer layer (bran) of the grains during the milling process. Diets rich in refined and processed foods, meats, and dairy products are low in magnesium content, in addition to increasing calcium absorption caused by protein consumption, and calcium retention caused by phosphorus consumption (often in the form of phosphates from processed foods and sodas).
Dietary magnesium intake has declined in the United States, with a per capita decline of magnesium in the U.S. food supply (estimated as food flowing through the food distribution system) of from 408 mg/day in 1909 to 329 mg/day in 1986, almost a 20% decline. This is believed to be a relatively small decline when compared to many decades earlier when unrefined and unprocessed foods, along with a consumption of less meats and dairy products, were the dietary standard in the U.S. This closely correlates with the chemical analysis of typical U.S. diets in the Food and Drug Administration""s Total Diet Study of 1976, 1977, 1980, 1981 and 1982, and with the United States Department of Agriculture""s 1985 average magnesium intake of adult men, and the USDA""s 1987 mean magnesium intake for adult women. The U.S. decline in dietary magnesium intake is directly attributable to the dietary decrease of unprocessed whole grains, legumes, seeds, and green plant foods, with a concurrent dietary increase of refined and processed foods, meats, sodas, and dairy products.
In those with normal digestion and assimilation, magnesium absorption from food is believed to be from approximately 40 to 60% of that ingested, with a slight reduction in absorption in the presence of phytate (a negatively charged form of phytic acid, i.e., inositol hexaphosphate found in plant leaves) or in the presence of fiber.
Magnesium depletion in humans can occur in those with inadequate dietary intake, excessive calcium intake (which disrupts calcium metabolism), excessive or prolonged levels of stress, gastrointestinal tract abnormalities associated with malabsorption, renal reabsorption dysfunction, excessive fluid and electrolyte losses of systemic or diuretic drug causes, and by the interference of certain drugs.
Large oral intakes of magnesium are generally regarded as safe, with no evidence of harm in those with normal renal function. It is known that excessive oral intakes of magnesium may cause transitory diarrhea.
Oral intakes of magnesium are naturally difficult for the body to absorb. It is believed that only 3 to 12% of elemental magnesium is absorbed for use by the body. Past attempts to increase the amount of magnesium made available for absorption by the body have been only partially successful until the development of compound complex magnesium.
While there is evidence that magnesium chelated with protein amino acids is more effectively absorbed by the body, passing more efficiently through the intestinal membrane into the blood than elemental magnesium, it is not completely clear how much more effective this is. Accordingly, there has been a degree of uncertainty attached to the selection of proper dosages of magnesium prior to the development of compound complex magnesium.
Compound complex magnesium is a compounded coordination complex of magnesium comprised of a coordination complex of magnesium, protein amino acids, and ascorbic acid in a ratio of 1:1:2, i.e., one part magnesium, one part protein amino acids, and two parts ascorbic acid, by weight. This composition of compound complex magnesium results in a balanced potential of hydrogen producing essentially a neutral pH factor (i.e., 0.0000001 gram atom of hydrogen ion per liter of solution essentially the same pH of distilled water). When prepared in the indicated manner, the anionic ascorbic acid component acts as a strong complexing agent capable of binding the cationic magnesium component, effectively producing a ligand coordination complex. In addition, the second complexing with the ascorbic acid component reinforces the first complexing of the magnesium component with the protein amino acids allowing it to reach its full potential, with an exponential increase in its potential for intestinal absorption, cell utilization and effectiveness. This double complexing process can be thought of as a stepped double complexing, or a compounded coordination complex, or a compound ligand, or simply a compound complex. This compounded coordination complex effectively potentiates the magnesium producing a composition which is essentially 100% available for intestinal absorption and cellular utilization resulting in maximum efficacy. Compound complex magnesium is an improvement over any other form of orally administered or ingested magnesium.
Compound complex magnesium has demonstrated greater intestinal absorption and cellular utilization, and when administered in effective amounts has the demonstrated ability to balance calcium metabolism, prevent dystrophic calcification, reduce and normalize blood pressure, relieve and control stress-induced cardiac arrhythmia extrasystole, prevent the formation of arterial plaque, prevent atherosclerosis, and to maintain the homeostasis of the cardiovascular system of the human body. This is more fully detailed in my prior U.S. Pat. No. 5,849,337 issued Dec. 15, 1998.
It is widely known that cardiovascular disease is the leading cause of death in the United States, as well as in most industrialized countries of the world. It is widely recognized that atherosclerosis is the main cause of cardiovascular disease. Atherosclerosis is characterized by calcified arterial plaque buildup, which results in reduced arterial blood flow and can eventually contribute to or manifest itself as heart attack, stroke, and peripheral arterial insufficiency. Calcified arterial plaque is arterial plaque that has been hardened by calcification with the mineral salt calcium. Recent advances in imaging equipment, most notably electron beam computed tomography, have made it possible to non-invasively and clearly view and measure calcified arterial plaque buildup in a functioning and beating heart without producing blurred images.
Recent research has revealed the main cause of calcified arterial plaque buildup to be unbalanced ionic calcium metabolism catalyzed by excessive free radicals in a collagen weakened arterial system of long duration. Ionic calcium is a form of calcium that is not bound to protein. It has been recently discovered that free unbound ionic calcium is the form of calcium that causes and contributes to cellular malfunction and unbalanced calcium metabolism, especially when ionic calcium is excessive and/or not balanced with a more bioavailable form of magnesium such as compound complex magnesium, and as a result causes and contributes to dystrophic calcification and the buildup of calcified arterial plaque at the sacrifice of other biologically important functions of calcium. Compound complex magnesium balances unbalanced calcium metabolism, preventing cellular malfunction and calcified arterial plaque buildup. There is a need for an improved form of calcium which can balance ionic calcium and not disrupt proper cellular function and not contribute to calcified arterial plaque buildup.
Past attempts at limiting arterial plaque buildup have generally been limited to controlling the xe2x80x9crisk factorsxe2x80x9d such as dietary fat and cholesterol reduction, blood cholesterol lowering medications, and blood pressure lowering medications, all with less than 100% effectiveness and with sometimes substantial deleterious side effects. Past invasive treatments for arterial plaque buildup have included angioplasty, shunt implant surgery, and arterial graft bypass surgery. In addition to the risks inherent with these procedures, the redevelopment of arterial plaque buildup is well documented with it being known to generally reoccur at an accelerated rate at the site of the procedure.
Therefore, a need exists for a method of administration of compound complex magnesium which can effectively reduce calcified arterial plaque buildup and cellular malfunction in the human body, and a method for making an improved form of calcium which can balance ionic calcium and not disrupt normal cellular function or contribute to calcified arterial plaque buildup.
Briefly, and in general terms, a method is described for reducing existing calcified arterial plaque buildup and reducing cellular malfunction in the human body when a compound complex form of magnesium is administered orally. This is accomplished by administering effective amounts of compound complex magnesium which allows for greater intestinal absorption and cellular utilization, which has the ability to improve cellular function and increase cellular efficiency by reducing cellular malfunction, balance calcium metabolism, prevent dystrophic calcification and maintain the homeostasis of the cardiovascular system of the human body. In addition, a method is described for making an improved form of calcium which can balance ionic calcium and not disrupt cellular function, not contribute to cellular malfunction and not contribute to calcified arterial plaque buildup.
In accordance with these discoveries, it is an object of the invention to provide a method for selectively administering an improved magnesium composition, known as compound complex magnesium, when administered in an effective amount, which can reduce the formation or buildup of calcified arterial plaque.
It is another object of the invention to provide a method for selectively administering compound complex magnesium, when administered in an effective amount, which can reverse or lessen the progression of atherosclerosis. The term xe2x80x9catherosclerosisxe2x80x9d is used herein to distinguish any form of cardiovascular disease, especially that which is characterized by arterial plaque formation or buildup, arterial constriction or spasm, thrombus formation, restricted or reduced arterial blood flow, or an increase in arterial blood pressure.
It is another object of the invention to provide a method for selectively administering compound complex magnesium, when administered in an effective amount, which can improve cellular function and increase cellular efficiency by reducing cellular malfunction.
It is another object of the invention to provide a method for making an improved form of calcium which can balance ionic calcium and not disrupt cellular function.
A further object of the invention is to provide an improved form of calcium which can balance ionic calcium which does not contribute to cellular malfunction.
A further object of the invention is to provide an improved form of calcium which can balance ionic calcium which does not contribute to dystrophic calcification.
A further object of the invention is to provide an improved form of calcium which can balance ionic calcium which does not contribute to calcified arterial plaque buildup.
A further object of the invention is to provide an improved form of calcium which can balance ionic calcium which is simple to produce and economically feasible to distribute on a commercial basis.
Other objects and advantages of this invention will become readily apparent from the ensuing detailed description and the clinical case studies.